Ann: Animal activity update - oxidative stress measurement system, page-15

We are continuing to make significant strides in the field of assisted reproductive technology (ART). With the recent progress in sales, product development, and clinical trials, we are poised to transform IVF procedures and reproductive health both in humans and animals.

The Felix™ System: A Game-Changer in IVF

Memphasys’s flagship product, the Felix™ System, has demonstrated remarkable success, achieving repeat commercial sales in Japan and facilitating multiple live births in Japan and India. This innovative automated device, which prepares sperm for IVF procedures, is designed to separate sperm from a semen sample in just six to seven minutes using electrophoresis and size exclusion membranes. Crucially, this process avoids any damage to sperm DNA, enhancing the chances of successful fertilisation.

To bolster the commercial roll-out of the Felix™ System, Memphasys has formed strategic partnerships with local subsidiaries of the Vitrolife Group in Japan, Canada, and New Zealand. Vitrolife Group, a global leader in the human IVF market, provides Memphasys with the clinical reach and sales capacity needed to penetrate these key markets.

Japan: A Major Milestone

Japan, one of the largest markets in the early access category, represents approximately 14.5% of the global IVF market. Memphasys’s partnership with Vitrolife Japan KK has opened immediate access to 20% of Japan’s unreimbursed IVF market. The initial integration includes sales to prestigious clinics like the Kobe ART clinic, with plans to expand into nine additional clinics.

Recent clinical trials in Japan have shown that the Felix™ System significantly reduces sperm processing time and improves key IVF outcomes compared to traditional methods. For instance, the blastocyst development rate with the Felix™ System was 58.4%, compared to 52.9% with traditional methods. Such promising results underscore the potential of the Felix™ System to enhance IVF success rates.

Expanding Reach: Canada and New Zealand

In early 2024, Memphasys secured exclusive distribution agreements with Vitrolife subsidiaries in Canada and New Zealand. These agreements mark a strategic move to build the Felix™ brand and establish credibility within these markets. Training and preliminary assessments are already underway, setting the stage for a broader market entry once the ongoing clinical trials conclude by year-end.

Advancements in Clinical Trials

The clinical trial of the Felix™ System, managed by Mobius Medical Pty Ltd, has gained considerable momentum. Conducted in collaboration with Monash IVF Group Ltd, the trial aims to assess the safety and performance of the Felix™ System against traditional sperm preparation techniques. With the “Swim-up” aspect completed and 50% of the Density Gradient Centrifugation (DGC) trial arm finished, the trial is on track for completion by the end of the year. Following this, results will be analysed, and regulatory submissions will be made to the Therapeutic Goods Administration (TGA).

Innovating with Oxidative Stress Measurement

Beyond human IVF, Memphasys is prioritising the development of its Oxidative Stress measurement system, which holds significant potential for the reproductive animal industry. Oxidative stress, caused by low levels of antioxidant protection, is linked to infertility and DNA damage in both sperm and eggs. The Oxidative Stress measurement system aims to provide rapid, point-of-care assessments, enabling immediate identification of animals requiring antioxidant supplementation.

Memphasys, in collaboration with industry partners, is designing a study to establish oxidative stress thresholds and their correlation with reproductive performance. This study will involve both longitudinal and retrospective analyses, with the aim of providing valuable insights to the animal industry.

Our advancements in the Felix™ System and the development of the Oxidative Stress measurement system highlight our commitment to enhancing reproductive health and success rates in both humans and animals